AbbVie (ABBV) announced that the U.S. Food and Drug Administration (FDA) approved HUMIRA (adalimumab) for the treatment of moderate to severe hidradenitis suppurativa or HS. HUMIRA is now the first and only FDA-approved therapy for adults with HS.
Hidradenitis suppurativa is a chronic inflammatory skin disease characterized by inflamed, painful lesions typically located around the armpits and groin, on the buttocks and under the breasts.
Earlier this year, the FDA granted HUMIRA orphan drug designation for the treatment of moderate to severe HS (Hurley Stage II and Hurley Stage III disease), a population of fewer than 200,000 patients. The orphan drug designation provides HUMIRA the potential to be granted seven years of market exclusivity for the treatment of moderate to severe HS.
In July, the European Commission approved HUMIRA for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adults with an inadequate response to conventional systemic HS treatment in the European Union.
Since first gaining approval 12 years ago, HUMIRA has been approved in more than 87 countries. It is currently being used to treat more than 843,000 patients worldwide.
by RTT Staff Writer